PORTEC-4a Trial setting: Stage I-II endometrial cancer - - - PowerPoint PPT Presentation

PORTEC-4a

Trial setting: Stage I-II endometrial cancer - high-intermediate risk Study Design: Randomised trial of molecular profile-based versus standard recommendations for adjuvant radiotherapy Sponsor(s): LUMC; funding: Dutch Cancer Society Planned No. of patients: 500 Current accrual: 46 Other important information: ANZGOG and NCRI UK preparing participation Ongoing Trials – status update

PORTEC-4a

Ongoing Trials – status update

• Molecular integrated vs standard indications for adjuvant treatment:

Surgery and pathology diagnosis FIGO 2009 – high intermediate risk Stage IA (with invasion), any age and grade 3 (with or without LVSI) Stage IB, grade 1-2 and age > 60 Stage IB, grade 1-2 and LVSI+ Stage IB, grade 3 without LVSI Stage II (microscopic), grade 1 Randomisation Endometrial carcinoma

PORTEC-4a

Ongoing Trials – status update

Individual treatment recommendation based on molecular pathology analysis 2 1 Standard treatment recommendation based on clinicopathological factors Vaginal brachytherapy Vaginal brachytherapy (~40%) Observation (~55%) External beam radiation therapy (~5%) Follow-up and Quality of Life Randomisation

Favourable Intermediate Unfavourable

PORTEC-4a

Ongoing Trials – status update

Pilot phase (n=50) endpoints:

• Logistics of molecular analysis

(< 2 wks)

• Patient acceptance
• Current: 46 / 50 pts

PORTEC-4a study endpoints (n=500):

• Vaginal control and RFS
• Pelvic and distant recurrence and OS
• Quality of life and freedom from

symptoms

• Costs and use of health care resources
• Satellite : Today, 2:30 h, State II Room